title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Background | Most mobile cessation studies have found that such interventions have a higher quitting rate than interventions providing minimal smoking cessation support. However, why such interventions are effective has been almost unstudied by researchers. | PMC10173036 | ||
Objective | This paper describes the principles of the personalized mobile cessation intervention-based WeChat app and used generalized estimated equations to assess why a personalized mobile cessation intervention was more likely to promote smokers from the preparation stage to the action stage than a nonpersonalized intervention... | PMC10173036 | ||
Methods | This is a 2-arm, double-blind, randomized controlled trial in five cities in China. The intervention group received a personalized mobile cessation intervention. The control group received a nonpersonalized SMS text message smoking cessation intervention. All information was sent by the WeChat app. The outcomes were th... | PMC10173036 | ||
Results | A total of 722 participants were randomly assigned to the intervention or control group. Compared with those who received the nonpersonalized SMS text message intervention, smokers who received the personalized intervention presented lower intrinsic rewards, extrinsic rewards, and response costs. Intrinsic rewards were... | PMC10173036 | ||
Conclusions | This study identified the psychological determinants at different stages to facilitate smokers moving forward to the next stage of quitting behavior and provides a framework to explore why a smoking cessation intervention is effective. | PMC10173036 | ||
Trial Registration | Chinese Clinical Trial Registry ChiCTR2100041942; https://tinyurl.com/2hhx4m7f | PMC10173036 | ||
Introduction | PMT | Smoking kills more than 1 million people in mainland China every year, and the number is predicted to grow to 2 million by 2030 and 3 million by 2050 [A large number of studies have shown that mobile cessation interventions can improve the smoking cessation rate and have the potential to provide smoking cessation servi... | PMC10173036 | |
Methods | PMC10173036 | |||
Design and Inclusion | DISEASE, RECRUITMENT | We conducted a 2-arm, double-blind, RCT in five cities in China (Beijing, Dezhou, Baotou, Yakeshi, and Linzi). Participants were randomized to an intervention group or a control group between April 2021 and July 2021. Daily or weekly smokers 18 years or older who smoked more than 5 cigarettes per week were eligible for... | PMC10173036 | |
Ethics Approval | The trial was approved by the Ethics Committee of Peking University Health Science Center (IRB00001052-30063). All the participants signed informed consent forms before randomization and knew that they could withdraw from the study at any time. All patients’ information was accessible only to the personnel participatin... | PMC10173036 | ||
Development of the Text Bank | PMT | The first stage was to develop the intervention message bank. Messages were developed by Peking University, School of Public Health, with the input of smokers and smoking cessation professionals. The messages had a three-layer framework. The first layer was divided based on time and consisted of the prequit message (1-... | PMC10173036 | |
Study Instruments | All messages were sent through the WeChat app (the most popular Chinese mobile chatting app) [The last stage was to deploy the message library on the WeChat platform by using IT. Our IT team completed the development process with several important considerations. First, the app needed to ensure the confidentiality of t... | PMC10173036 | ||
Randomization and Blinding | RECRUITMENT | After recruitment, the participants were required to complete the baseline questionnaire and register through WeChat. A randomized block design was used, and the score of the Fagerström Test for Nicotine Dependence was treated as a stratified factor. The WeChat system automatically generated two blocks by the score of ... | PMC10173036 | |
Intervention and Control Group | Cancer | CANCER | All participants were informed that the eighth day after randomization would be their quit day. Participants who were allocated to the intervention group received the program of interventions. As described above, this consisted of 1-2 personalized SMS text messages per day for 3 months.Control group participants receiv... | PMC10173036 |
Measures | TTM | PMT | All participants in the two groups were instructed to attend face-to-face follow-ups with research staff 1 month, 3 months, and 6 months after randomization. The outcomes were the change in PMT construct scores and the change in TTM stages. TTM stages of change were measured by smoking status using the question “Are yo... | PMC10173036 |
Statistical Analysis | PMC10173036 | |||
Sample Size Calculation | The sample size calculation was based on the formula for a 2-arm RCT. Based on earlier research, we estimated that biochemically verified continuous smoking abstinence at 6 months would be approximately 4% in the control group and 10% in the intervention group [
| PMC10173036 | ||
Data Analysis | PMT | Our data analysis was conducted in three steps. First, we used generalized estimating equations (GEEs) to analyze the changes in TTM stages by group. Second, we analyzed the associations between PMT construct scores and the change in TTM stages. Third, we assessed PMT construct score changes in the two groups to explor... | PMC10173036 | |
Step 1 | A GEE was used to address the correlated nature of the repeated measures in the data [ | PMC10173036 | ||
Step 2 | REGRESSION, PMT | To examine the psychological determinants of movement from the precontemplation to the action period, we changed the explanatory variables to PMT construct scores. We used the second GEE to assess which PMT constructs were associated with the TTM stage of change. We chose an exchangeable correlation structure for the m... | PMC10173036 | |
Step 3 | REGRESSION, PMT | We estimated the impact of the intervention on PMT construct scores in the last set of models to explore the reasons why the intervention group was more likely to promote smokers from the preparation stage to the action stage. The dependent variables included seven PMT constructs (severity, vulnerability, intrinsic rew... | PMC10173036 | |
Discussion | PMC10173036 | |||
Principal Findings | adversity | PMT | This study engages in the debate in recent years over the effects of mobile cessation interventions. It provides a more comprehensive picture of the impact of personalized mobile cessation interventions from psychological change perspectives using Chinese data. It successfully shows that the intervention group had lowe... | PMC10173036 |
Conclusion | This study reported clearly on the development of a mobile cessation intervention. GEE analysis identified the psychological determinants of forward movement in the stage of change and confirmed that a personalized mobile cessation intervention was more likely to promote smokers from the preparation stage to the action... | PMC10173036 | ||
Abbreviations | generalized estimating equationodds ratioprotection motivation theoryrandomized controlled trialtranstheoretical model | PMC10173036 | ||
Data Availability | The data of the studies is accessible through the Peking University School of Public Health. | PMC10173036 | ||
Background | GDM | GDM, GESTATIONAL DIABETES MELLITUS | Edited by: Victor Khin Maung Han, Lawson Health Research Institute, CanadaReviewed by: Mengzhi Wang, Yangzhou University, China; Zhonghua Shi, Nanjing Medical University, ChinaThis article was submitted to Developmental Endocrinology, a section of the journal Frontiers in EndocrinologyGut microbiota of pregnant women c... | PMC9911812 |
Objective | This study aims to evaluate the feasibility and acceptability of prebiotic intervention in healthy pregnant women during pregnancy, and to explore the possible effects of intervention on pregnant women and the influence on gut microbiota as preliminaries. | PMC9911812 | ||
Methods | RECRUITMENT | After recruitment in first trimester, 52 pregnant women were randomly assigned to receive GOS intervention or placebo containing fructooligosaccharides. 16S rRNA sequencing technology was used to detect the composition, diversity and differential flora of gut microbiota. Lipid metabolism, glucose metabolism and inflamm... | PMC9911812 | |
Results | weight gain, GDM, TG | GDM | The adverse symptoms of GOS intervention are mild and relatively safe. For pregnant women, there was no significant difference in the GDM incidence rates and gestational weight gain (GWG) in the GOS group compared with placebo (P > 0.05). Compared with the placebo group, the levels of FPG, TG, TC, HDL-C LDL-C, and IL-6... | PMC9911812 |
Conclusions | GOS prebiotics appear to be safe and acceptable for the enrolled pregnancies. Although GOS intervention did not show the robust benefits on glucose and lipid metabolism. However, the intervention had a certain impact on the compostion of gut microbiota. GOS can be considered as a dietary supplement during pregnancy, an... | PMC9911812 | ||
Introduction | PROLIFERATION | With the change of gestational age, gut microbiota is participated in the physiological adaptation of maternal metabolism (Different from probiotics, galactooligosaccharides (GOS) is a kind of prebiotics that aren’t digested and absorbed by the host, but can selectively promote the metabolism and proliferation of benef... | PMC9911812 | |
Materials and methods | PMC9911812 | |||
Study population | impaired fasting glucose, hypertension, chronic diseases, diabetes | HYPERTENSION, IMPAIRED GLUCOSE TOLERANCE, CHRONIC DISEASES, DIABETES | We conducted a prospective double-blinded randomized clinical trial involving singleton pregnancy women. Inclusion criteria were: 18-40 years of age; living in Beijing; understanding and willing to sign informed consent; singleton pregnancy; first prenatal care visit between 5-8 weeks of gestation. Exclusion criteria w... | PMC9911812 |
Study design and intervention | During this double-blinded, parallel-group clinical study, participants were randomly assigned to the control group and the intervention group at a 1:1 ratio. Women participants who meet the eligibility criteria were recruited and stratified according to their body mass index (BMI). All participants were divided into f... | PMC9911812 | ||
Data and sample collection | BLOOD, STERILE | Participants were enrolled at 5-8 weeks of gestation. Blood and stool samples were collected and followed up at 11-13 weeks of gestation and 24-28 weeks of gestation. During the follow-up period, filled in the questionnaire during the corresponding pregnancy, and left the participants’ blood samples and stool samples a... | PMC9911812 | |
Study outcomes | weight gain, GDM, TG, diabetes | GDM, SECONDARY, ADVERSE REACTIONS, DIABETES | For the primary study outcomes, the effect of GOS on maternal gut microbiota were reported. At the same time, for those who have been followed up to the second trimester of pregnancy, based on the results of 75g oral glucose tolerance test (OGTT) at 24-28 gestational weeks (For pregnant women, baseline data such as age... | PMC9911812 |
DNA extraction and V3–V4 region of 16SrRNA gene sequencing | A commercial kit (Qiagen, Hilden, Germany) were used to extract faecal DNA. Faecal DNA was amplified by PCR using 16S amplicon PCR forward primer and 16S amplicon PCR reverse primer. After PCR amplification, the amplicons in each library were purified by Qiagen for library preparation. Subsequently, the qualified libra... | PMC9911812 | ||
Sample size | RECRUITMENT, EARLY PREGNANCY | The purpose of this pilot study was to eavluate the feasibility and acceptability of prebiotics for pregnant women. A total of 52 pregnant women were considered enough to provide practical recruitment, feedback and compliance information. The findings will provide basis and support for future a large sample trial to ev... | PMC9911812 | |
Statistical analysis | Data were represented as mean ± standard deviation (SD) or count (%). All data were input into SPSS (version 25.0) to analyze. GraphPad prism (version 8.0) was used to draw diagrams. χ2 and Fisher’s exact test was used for categorical variables, and t-test or non-parametric Wilcoxon test was used for continuous variabl... | PMC9911812 | ||
Results | PMC9911812 | |||
Participants enrollment and clinical baseline | GDM | GDM, GESTATIONAL DIABETES MELLITUS | Flow of participants through the study is shown in Flow chart of participants through the study.Baseline characteristics of study participants.Data presented are mean ± SD or n (%).P-values for comparisons between the 2 groups in t-tests for continuous variables, and χ2 and Fisher’s exact tests for categorical variable... | PMC9911812 |
Effects of prebiotics on gut microbiota in pregnant women | PMC9911812 | |||
Overall microbial structures of gut microbiota | We studied gut microbiota of women in placebo and GOS groups. Relative abundance at the level of bacterial phylum. | PMC9911812 | ||
Changes of gut microbiota diversity | To assess the gut microbiota community structure, richness (Chao 1 index) and diversity (Simpson index, Shannon index) were calculated (Alpha and beta diversity of gut microbiota in placebo and GOS groups. To compare overall gut microbiota structure in pregnant women, PCoA according to OTUs of each sample were implemen... | PMC9911812 | ||
Changes in specific bacterial taxa | For identify the changes in specific bacterial taxa after prebiotics supplemented intervention. We utilized the linear discriminant analysis (LDA) effect size (LEfSe) to compare the gut microbiota composition between placebo and GOS groups. The LDA score was selected to discriminate specific taxa in two groups. Compare... | PMC9911812 | ||
Participants clinical outcomes | PMC9911812 | |||
GDM diagnosis and OGTT values | GDM | GDM, GESTATIONAL DIABETES MELLITUS | Serum levels of FBG, 1-hour and, 2-hour OGTT plasma glucose measured at 24–28 weeks of pregnancy in women who received either GOS or placebo are illustrated in GDM diagnosis and OGTT values.GDM, gestational diabetes mellitus; OGTT, oral glucose tolerance test. | PMC9911812 |
Changes in weight and BMI during pregnancy | weight gain | With the change of gestational weeks, we collected the weight gain during pregnancy of two groups of pregnant women, and calculated the changes of BMI (Changes in weight and BMI during pregnancy.BW, body weight; BMI, body mass index; BW 1st, body weight at the beginning of 1st trimester; BW 3rd, body weight at the end ... | PMC9911812 | |
Clinical characteristics of neonates | To investigate the impact of the intervention on neonatal outcomes, we measured the following variables including gestational week, birth weight, birth length, head circumference, chest circumference, sex, and delivery mode. No significant difference was found between the GOS and placebo group (all P-values were > 0.05... | PMC9911812 | ||
Glucose metabolism, lipid metabolism and inflammatory factor levels | In order to further explore the effect of prebiotics intervention on glucose metabolism, lipid metabolism, and immunity, we analyzed the following indicators (Glucose metabolism, lipid metabolism and inflammatory factor levels.FPG, fasting plasma glucose; TG, triglyceride; TC, total cholesterol; HDL-C, high-density lip... | PMC9911812 | ||
Incidences of maternal and infant complications | COMPLICATIONS | Clinical data on the incidences of maternal and infant complications were also collected (Incidences of maternal and infant complications. | PMC9911812 | |
Safety of intervention | nausea | A questionnaire was used to record the possible severity of adverse symptoms in pregnant women and the relationship between symptoms and the ingestion of preparations. The results showed that one participant in GOS group had abdominal distension and one participant had nausea. These symptoms have little to do with the ... | PMC9911812 | |
Discussion | GDM, disorder of gut microbiota | OF PREGNANCY COMPLICATIONS, METABOLIC DISEASES, GDM | During pregnancy, the disorder of gut microbiota and abnormal glucose metabolism may be the possible mechanism of pregnancy complications such as GDM (The preliminary conclusion of this study is that GOS intervention has no significant effect on reducing the incidence of GDM and improving glucose and lipid metabolism. ... | PMC9911812 |
Conclusion | GOS prebiotics appear to be safe and acceptable for the enrolled pregnancies. Although GOS intervention did not show the robust benefits on glucose and lipid metabolism. However, the intervention had a certain impact on the compostion of gut microbiota. GOS can be considered as a dietary supplement during pregnancy, an... | PMC9911812 | ||
Data availability statement | The raw sequence data of the 16S rRNA gene supporting the results of this article are available in the NCBI database, SRA data (Accession number: PRJNA925813). | PMC9911812 | ||
Ethics statement | The studies involving human participants were reviewed and approved by Clinical Trial Ethics Committee, Peking University First Hospital, Beijing, China. The patients/participants provided their written informed consent to participate in this study. | PMC9911812 | ||
Author contributions | HY | JW collected the data, prepared tables and figures, and drafted the paper. LA and ZR analyzed the data and prepared tables. SW, LA, HY, and JM conceived and designed the research. JM revised the manuscript. HY and JM provided clinical supervision. All authors contributed to the article and approved the submitted versio... | PMC9911812 | |
Acknowledgments | The authors would like to thank all the participants in this study, the Beijing Natural Science Foundation—San Yuan Joint Research Fund for providing technical support and the Institute of Microbiology, Chinese Academy of Sciences for providing support in sequencing analysis. We thank all the staff at the Department of... | PMC9911812 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC9911812 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC9911812 | ||
References | PMC9911812 | |||
Key Points | PMC10425831 | |||
Question | acute ischemic stroke, AIS | Does ginkgo diterpene lactone meglumine (GDLM) improve the functional outcome at 90 days in patients with acute ischemic stroke (AIS)? | PMC10425831 | |
Findings | 3448 | ADVERSE EVENTS | This randomized clinical trial included 3448 patients with AIS who received GDLM or placebo injections within 48 hours after symptoms for 14 days; the proportion of patients achieving a favorable outcome, defined as the 90-day modified Rankin Scale score of 1 or 0, was 50.8% in the GDLM group, significantly higher than... | PMC10425831 |
Meaning | Among patients with AIS, ginkgo diterpene lactone meglumine improved the proportion of patients achieving favorable clinical outcomes at 90 days compared with placebo. | PMC10425831 | ||
Importance | acute ischemic stroke, AIS | ISCHEMIC STROKE | Ginkgo diterpene lactone meglumine (GDLM) has attracted much attention because of its potential neuroprotective properties in ischemic stroke. The efficacy of GDLM in patients with acute ischemic stroke (AIS) needs to be verified by well-designed randomized clinical trials. | PMC10425831 |
Objective | To assess the efficacy and safety of GDLM in patients with AIS. | PMC10425831 | ||
Design, Setting, and Participants | stroke, stroke disability, death, Stroke | STROKE, MAY, STROKE | This multicenter, randomized, double-blind, placebo-controlled, parallel-group trial involved 3448 patients who had AIS, were aged 18 to 80 years, had a clinically diagnosed AIS symptom within 48 hours of onset, had a modified Rankin Scale (mRS) score of 0 or 1 prior to onset, and had a National Institutes of Health St... | PMC10425831 |
Interventions | Patients were randomized to receive GDLM or placebo once daily via intravenous infusion in a 1:1 ratio. The treatment was dispensed within 48 hours after symptoms and continued for 14 days. Interventions of thrombolysis and thrombectomy were not permitted during the treatment. | PMC10425831 | ||
Main Outcomes and Measures | ADVERSE EVENTS | The primary outcome was the proportion of patients with an mRS of 0 or 1 on day 90 after randomization. Safety outcomes included adverse events and serious adverse events. | PMC10425831 | |
Results | A total of 3448 patients were randomized, with 1725 patients assigned to the GDLM group and 1723 patients assigned to the placebo group. The median (IQR) age of the patients was 63 (55-71) years, and 1232 (35.7%) were women. The primary outcome on day 90 occurred in 877 patients (50.8%) in the GDLM group, and 759 patie... | PMC10425831 | ||
Conclusions and Relevance | Among patients with AIS in this randomized clinical trial, GDLM improved the proportion of patients achieving favorable clinical outcomes at 90 days compared with placebo. | PMC10425831 | ||
Trial Registration | acute ischemic stroke | ClinicalTrials.gov Identifier: This randomized clinical trial assesses the safety and functional outcomes at 90 days of ginkgo diterpene lactone meglumine, a neuroprotective agent, in patients with acute ischemic stroke. | PMC10425831 | |
Introduction | excitotoxicity, acute ischemic stroke, AIS | INFLAMMATION | Neuroprotection has emerged as a potential therapeutic approach in patients with acute ischemic stroke (AIS). Multiple pathological and physiological processes are involved in the occurrence and progression of AIS, including excitotoxicity, oxidative and nitrosative stress, cell apoptosis, and inflammation. | PMC10425831 |
Methods | PMC10425831 | |||
Trial Design | bleeding | BLEEDING, EVENT, MAY, SECONDARY, EVENTS | This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial conducted at 100 centers in China from February 1, 2016, to May 1, 2018. Details of the trial rationale, design, and methods were provided in the trial protocol (The steering committee was responsible for the design and supervisi... | PMC10425831 |
Patient Eligibility Criteria | stroke, stroke disability, death, Stroke | STROKE, STROKE | Patients were eligible if they were aged 18 to 80 years, had a clinically diagnosed AIS symptom within 48 hours of onset, had a modified Rankin Scale (mRS) score of 0 or 1 prior to onset, had a National Institutes of Health Stroke Scale (NIHSS) score between 4 and 24 after onset (indicating moderate stroke), had an upp... | PMC10425831 |
Randomization and Blinding | Within 48 hours after symptom onset, eligible patients were randomly assigned in a 1:1 ratio to receive GDLM or placebo by a computerized block randomization method with randomly selected block sizes of 4. The randomization number was stimulated centrally by an independent statistician. The 2 forms of drugs were visual... | PMC10425831 | ||
Treatment | STERILE | Patients in the GDLM group received a GDLM injection of 5 mL (active ingredient GDLM, 25 mg) once daily via intravenous infusion for 14 consecutive days. Patients in the placebo group received a GDLM mimic injection (physiological saline) of 5 mL once daily via intravenous infusion for 14 consecutive days. Both the GDL... | PMC10425831 | |
Outcomes | ADVERSE EVENTS, SECONDARY | The primary efficacy outcome was the proportion of patients with a mRS score of 0 or 1 on day 90 after randomization. The secondary outcomes included the proportion of patients with an mRS score of 2 or less on day 90 after randomization, the proportion of patients with a decrease in NIHSS score of at least 4 points fr... | PMC10425831 | |
Statistical Analysis | We determined that a total of 3452 patients would provide 80% power to detect a 45% rate of patients with mRS scores of 0 or 1 on day 90 after randomization in the placebo groupAll the analyses were performed in the modified intention-to-treat population, which comprised all the patients who had undergone randomization... | PMC10425831 | ||
Results | PMC10425831 | |||
Baseline Characteristics | A total of 3452 patients with AIS were enrolled at 100 centers in China. A total of 1726 were assigned to receive GDLM, and 1726 were assigned to receive placebo ( | PMC10425831 | ||
Flowchart of the Study | stroke, Stroke | STROKE, STROKE | Abbreviations: GDLM, ginkgo diterpene lactone meglumine; NIHSS, National Institutes of Health Stroke Scale. The NIHSS is a tool used by clinicians to quantify impairment caused by stroke (range, 0-42, with higher scores indicating greater severity).The characteristics of the patients at baseline were well balanced betw... | PMC10425831 |
Baseline Characteristics | stroke, Stroke | STROKE, STROKE | Abbreviations: GDLM, ginkgo diterpene lactone meglumine; NIHSS, National Institutes of Health Stroke Scale.Body mass index is calculated as weight in kilograms divided by height in meters squared.The NIHSS is a tool used by clinicians to quantify impairment caused by stroke (range, 0-42, with higher scores indicating g... | PMC10425831 |
Outcomes | PMC10425831 | |||
Primary Outcome | In the modified intention-to-treat analysis, 877 (50.8%) of 1725 patients in the GDLM group and 759 (44.1%) of 1723 patients in the placebo group reached the primary outcome (mRS score of 0 or 1 at 90 days; risk difference, 6.79%; 95% CI, 3.46%-10.10%; OR, 1.31; 95% CI, 1.15-1.50; RR, 1.15; 95% CI, 1.08-1.24; | PMC10425831 | ||
Efficacy Outcomes | stroke, stroke disability, Stroke | REGRESSION, STROKE, STROKE | Abbreviations: GDLM, ginkgo diterpene lactone meglumine; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale.The mRS is a global stroke disability scale with scores ranging from 0 (no symptoms or completely recovered) to 6 (death).The NIHSS is a tool used by clinicians to quantify impairment c... | PMC10425831 |
Distribution of 90-Day Modified Rankin Scale (mRS) Score | stroke disability, death | The mRS is a global stroke disability scale with scores ranging from 0 (no symptoms or completely recovered) to 6 (death). Each cell corresponds to a score on the mRS; the width of the cell indicates the proportion of patients with equivalent scores. The percentage of patients in each category is shown within the cell.... | PMC10425831 | |
Secondary Outcomes | SECONDARY | With respect to secondary outcomes, the proportion of patients with a favorable functional outcome (mRS score of 0-2) in the GDLM group was 83.8% compared with 69.5% in the placebo group (risk difference, 14.35%; 95% CI, 11.56%-17.12%; OR, 2.28; 95% CI, 1.93-2.68; RR, 1.21; 95% CI, 1.16-1.25; | PMC10425831 | |
Odds Ratio for the Primary Outcome in Prespecified Subgroups | The | PMC10425831 | ||
Safety Outcomes | ADVERSE EVENTS | The GDLM group and the placebo group had a similar incidence of adverse events (303 [17.6%] vs 298 [17.3%]; risk difference, −0.27%; 95% CI, −2.26%-2.80%; OR, 1.02; 95% CI, 0.85-1.21; RR, 1.02; 95% CI, 0.88-1.17; | PMC10425831 | |
Discussion | cardiocerebrovascular diseases | ACUTE ISCHEMIC STROKE | In this randomized, double-blind, placebo-controlled, parallel-group clinical trial, GDLM dispensed within 48 hours after symptoms for patients with AIS improved the proportion of patients achieving a 90-day favorable functional outcome, which was defined as an mRS score of 0 or 1, compared with placebo.Neuroprotective... | PMC10425831 |
Limitations | ischemic stroke | ISCHEMIC STROKE | Several limitations in the present study need to be addressed. First, because the current trial was mainly conducted among patients with Han Chinese backgrounds, caution should be taken when generalizing these findings to other ethnic groups. Additionally, patients with ischemic stroke in this trial did not receive int... | PMC10425831 |
Conclusions | The current randomized clinical trial indicated that among patients with AIS treated within 48 hours after onset, the 14-day treatment of GDLM could improve the proportion of patients achieving good clinical outcomes at 90 days compared with placebo. | PMC10425831 | ||
Acknowledgements | Hilary North prepared the manuscript. | PMC10176668 | ||
Author contributions | LSS, NJI, ABH | Trial, analysis conceived by SMC, SD, LSS, and MG (YIS assisted). ABH and YIS conducted trial operations. AOC, RM, and MG monitored trial safety. KB and HZ conducted Aβ monomer ELISA in CSF; MEH analyzed data. CMY, HME, WDG, and JRC developed, validated AβO MIE assay and conducted CSF sample measurements and analysis. ... | PMC10176668 | |
Funding | This work was supported by grants from the National Institute on Aging (AG057780 to SMC) and by Cognition Therapeutics, Inc. Content is solely the authors’ and does not represent the National Institutes of Health. | PMC10176668 | ||
Availability of data and materials | All data needed to evaluate the conclusions are presented here or available upon request. | PMC10176668 |
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